Chantix Approval Revoked in France

Chantix has been removed from Franceâ€™s list of state-approved drugs. The move followed issues concerning side effects linked to the controversial smoking cessation remedy, said The Day. Chantix (generic: varenicline) is known as Champix in Europe and is manufactured by Pfizer Inc.

The U.S. Food and Drug Administration (FDA) approved Chantix in the United States in 2006 as a treatment for smoking cessation. Chantix blocks nicotine by targeting the brainâ€™s nicotine receptors. About a year after being on the market, reports began emerging about patients exhibiting strange and dangerous behavior while on Chantix; the FDA received a number of adverse event reports and issued information on the potential risks. In 2009, the FDA announced that a Boxed Warning would be added to the Chantix label.

We recently wrote that a study from the Institute for Safe Medication Practices (ISMP) suggested a link between some prescription drugsâ€”including Chantixâ€”and violent behavior. The study revealed that Chantix is a whopping 18 times likelier to be associated with â€œviolence and aggressionâ€ versus other drugs. According to WebMD and Thomas J. Moore, senior scientist for drug safety and policy at the ISMP, Chantix has so much potential danger it should contain restrictions including exclusions for police, military, and others who must carry weapons.

French health minister, Xavier Bertrand, announced that his decision to remove Chantix from that countryâ€™s list of approved drugs available to receive reimbursement from Franceâ€™s social security funds, was driven by safety issues, said The Day. “It will no longer be covered by health insurance,” Bertrand told a French television network, according to Reuterâ€™s news service, quoted The Day.

The FDA recently asked Pfizer Inc., to submitâ€”againâ€”a large amount of its adverse event reports from 2010 for the drug. On its website, the FDA wrote that it became aware that Pfizer was among drug makers processing adverse event reports through what the agency described as â€œimproperâ€ channels. Adverse events are reported to the FDA either through periodic safety summary reports or via quicker reporting through its adverse event reporting system (AERS). Reports that discuss side effects covered on the medicationâ€™s labeling can be submitted through periodic reports; however, reporting of what the Wall Street Journal described as â€œunexpected or fatalâ€ events must be filed as 15-day reports to AERS. The FDA said it asked Pfizer to resubmit â€œthousandsâ€ of reports submitted as periodic summaries to AERS.

ISMP said 1,055 serious adverse events reports were linked to Chantix in 2010â€™s third quarter, including 150 suicides. The ISMP also said that the total included 589 serious adverse event reports prior to 2010, but which were entered into AERs in July 2010, said the Journal.

The FDA said that the revised data, which increased the number of suicides more that two-fold during third quarter 2010, does not affect its standing on the drugâ€™s efficacy and risks. “These reports confirm what we already knew about Chantix,” the agency said in a statement, quoted The Day. “At this point, based on the data, FDA does not have any new safety concerns with Chantix, though those that have been established remain under active review,” the agency added.

“The ISMP found 150 cases of completed suicides, some of which dated back to 2007, that were not reported promptly,” explained Ed Silverman in Pharmalot, quoted The Day. “Instead, the drugmaker apparently coded the suicides as ‘expected adverse events’ among 26,000 such events, and added these to a quarterly periodic report, which is how less important, non-serious side effects are sent to the FDA.”

Most recently, the estates of a couple killed in a murder-suicide two years ago filed a Chantix lawsuit against Pfizer Inc.â€”one of many such lawsuits the drugmaker now faces. This lawsuit alleges that Chantix prompted the rage that led to the fatal events in which Sean Wain, 34, killed his wife Natalie, 33, before killing himself in May 2009. The Wainâ€™s had four children. Mr. Wain was taking Chantix for one week prior to the murder-suicide.